Biomedical Engineer
LEDE2 Consulting LLC
- Frederick, MD
- $95,000-105,000 per year
- Permanent
- Full-time
- Analyze medical equipment using maintenance data, usage and life cycle data, technology standards.
- Provide input and written reports, evaluations and recommendations fixed facility hospitals on their standard of care.
- Ensure that the biomedical equipment is in compliance with applicable regulatory requirements and quality control standards.
- Create and evaluate Systems Requirements Documents (SRD's) for purchase criteria within each Request for Offer package (RFO)
- Evaluate RFO packages conducting down selections for equipment purchases through the Defense Logistics Agency (DLA)
- Assist with design, help develop and provide safety testing, repair, and maintenance of biomedical equipment.
- Participate and actively engage on Integrated Product Teams (IPT) and Working Groups (WG) as a Chartered Member and serve as the technical expert by providing expert advice.
- Prepare and deliver documents ranging from technical reviews to acquisition documentation.
- Conduct market analysis to include available products and industries, gain an understanding of product market survivability and viability as a crucial component for the execution of force-wide fielding.
- Review test plans, and results and reports from clinical studies and other testing, to include the review of the final study reports at the end of each phase of a clinical study, and/or lab results from testing facilities.
- Assist the PdM's in review of regular Program Objective Memorandum (POM) cycles, spend plans, cost estimating and other cost analysis requirements.
- Monitor, track and report on program cost, schedule and performance.
- Bachelor's Degree in related field with 4 years related experience; or a minimum of 7 years related experience in lieu of a degree.
- Must be a U.S. Citizen and have the ability to obtain NACI (background investigation) clearance.
- Seven (7) years of experience with medical product development, DoD T&E requirements, and regulatory approval processes
- The ability to travel to fixed facility hospitals is possible (potential for 2-8 trips annually)
- Prepare and deliver documents ranging from technical reviews to acquisition documentation.